Drug delivery devices allowing for multiple dosing of a required dosage of a liquid medicinal product, such as liquid drugs, and further providing administration of the liquid to a patient, are as such well-known in the art. Generally, such devices have substantially the same purpose as that of an ordinary syringe.
Pen-type injectors of this kind have to meet a number of user specific requirements. For instance in case of those with diabetes, many users will be physically infirm and may also have impaired vision. Therefore, these devices need to be robust in construction, yet easy to use, both in terms of the manipulation of the parts and understanding by a user of its operation. Further, the dose setting must be easy and unambiguous and where the device is to be disposable rather than reusable, the device should be inexpensive to manufacture and easy to dispose. In order to meet these requirements, the number of parts and steps required to assemble the device and an overall number of material types the device is made from have to be kept to a minimum.
Some medicinal products, for instance insulin, heparin or growth hormones have to be stored in a refrigerated environment in order to prevent disintegration or decomposition. Some medicinal products that are typically subject to self-administration may even rapidly decompose when exposed to ambient temperatures above an admissible threshold. Since handling and storage of such drug delivery devices and associated medicinal products is entirely in the responsibility of the patient himself, there exists a significant risk to health, when for instance the medicinal product has not been stored properly prior to administration.
Administering a dose of a medicinal product that has been improperly stored or otherwise improperly treated may lead to severe consequences for the health of the patient. Even a short-term and singular rise of the ambient temperature may lead to a substantial disintegration of a medicinal product, which is unfortunately not visible to the end user. In such cases, where the user is not aware that a critical rise in temperature has occurred, the user has no reason to believe, that the medicinal product might be substantially ineffective or even harmful.
Additionally, even in such cases, where the user has become aware of an at least temporally improperly stored medicinal product and/or medical device, the user, due to a lack of experience, may play down the potential harmful effect of improperly stored drugs and/or devices.
In any case, the user or patient may be exposed to a considerable risk to health, once a drug delivery device and/or a cartridge containing a respective medicinal product has been improperly stored or otherwise improperly treated.